CompletedNCT01880333Updated Jan 15, 2019

Evaluation of the Modified Atkins Diet in Young Children With Refractory Epilepsy

A Phase 2/3 interventional study of Modified Atkin Diet in Refractory Epilepsy, sponsored by Lady Hardinge Medical College. Completed at 1 site in India. Open to participants aged 9 Months to 3 Years. Per ClinicalTrials.gov, last updated 2019-01-15.

Sponsored by Lady Hardinge Medical College · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 31
Allocation: Not applicable
Ages: 9 Months to 3 Years
Sex: All

Study summary

The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy that was designed to be a less restrictive alternative to the traditional ketogenic diet. This diet is started on an outpatient basis without a fast, allows unlimited protein and fat, and does not restrict calories or fluids. Modified Atkins diet is of special importance in resource constraint settings with paucity of trained dieticians. However, there is paucity published data on the use of the modified Atkins diet in refractory epilepsy in young children. This study aims to evaluate the efficacy and tolerability of the modified Atkins diet in refractory epilepsy in young children.

Conditions studied

Refractory Epilepsy

Browse trials for

Drug Resistant Epilepsy 270

Keywords

Refractory epilepsy
dietary therapy
non-pharmacological therapy
Modified Atkin Diet

In context

Drug Resistant Epilepsy

270 studies on the registry are indexed under Drug Resistant Epilepsy; 100 are open to participants now.

This study's enrollment of 31 is close to the median of 30 across 213 interventional studies indexed under Drug Resistant Epilepsy.

Browse Drug Resistant Epilepsy studies →

Lead sponsor

Lady Hardinge Medical College is the lead sponsor of 34 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 9 Months to 3 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age: 9 months to 3 years.
Seizures persisting at least three per week for > 1 month despite the appropriate use of at least 2 Anti-epileptic drugs.

Exclusion criteria

Exclusion Criteria:

Known or suspected inborn error of metabolism, as evidenced by: Clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination And/ or 2 or more of the following biochemical abnormalities High blood ammonia (>80mmol/L), High arterial lactate (>2 mmol/L), metabolic acidosis (pH \<7.2), hypoglycaemia (blood sugar \<40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests.
Motivational or psychosocial issues in the family which would preclude compliance
Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease
Severe acute malnutrition.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 31 participants (actual)

Study arms

Experimental
Children on Modified Atkin Diet
Other: Modified Atkin Diet

Interventions

OtherModified Atkin Diet
Eligible children will be started on Modified Atkins diet with help of trained dietician. Carbohydrates intake will be restricted to 5 grams/ day in children\<18 mo and 10grams/day in children 18mo- 3 years.Carbohydrate values of various food items will be explained in detail. Fats (e.g. cream, butter, oils, and ghee) will be encouraged. Proteins (cheese, fish, eggs, chicken, and soya products) will be unrestricted. Calcium and multivitamin supplementation will be done. Syrups will be restricted. Clear carbohydrates free fluids- will not be restricted. Medications will be changed to carbohydrate free preparations, wherever available. Diary of events will be recorded including seizure frequency and any adverse or positive effect. Urine ketones chart will be maintained.

What researchers measure

Primary outcomes

Proportion of children with > 50% seizure reduction at 3 months
Time frame: After 3 months of diet initiation

Secondary outcomes

Frequency of adverse effects of the modified Atkins diet.
Time frame: 3 months

Other outcomes

Proportion of children with seizure freedom at 3 months
Time frame: 3 months
Percentage of children discontinuing diet before 3 months as per parenteral reports
Time frame: 3 months

Study locations

1 site

Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
New Delhi, National Capital Territory of Delhi 110001, India

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2012, a primary completion of Mar 2014 and a completion of Mar 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 13, 2013
First posted: Jun 18, 2013
Start: Nov 2012
Primary completionActual: Mar 2014
CompletionActual: Mar 2014
Last update: Jan 15, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01880333
Lead sponsor: Lady Hardinge Medical College
Responsible party: Satinder Aneja (Director Professor, Lady Hardinge Medical College) — Principal investigator
First posted: Jun 18, 2013
Start date: Nov 2012
Primary completion: Mar 2014
Completion: Mar 2014
Last update: Jan 15, 2019

Study contacts

Satinder Aneja, MD

principal investigator · Kalawati Saran Children's Hospital, Lady Hardinge Medical College, New Delhi, India

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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